Q72 – 81: Product Infusion

Question 72: Date of manipulated product infusion

Report the date (YYYY-MM-DD) this product was infused. If the product was infused over multiple days, report the first date of infusion.
If the exact date is unknown, please view General Instructions, General Guidelines for Completing Forms for more information on reporting partial and unknown dates.

Questions 73 – 75: Was the entire volume of product infused?

The intent of this question is to capture if the product being infused was given in its entirety. If the entire volume of the product was not infused, select No and specify what happened to the reserved portion. If Other fate is selected, specify what happened to the reserved portion of the product.

Questions 76 – 77: Specify the route of product infusion

Report the route by which the product was infused.

• Intravenous: refers to the infusion into the veins. Examples include infusion via central line or via catheter.
• Other route of infusion: If the product was infused other than intravenously, select this option and specify the other route. This option should be used sparingly since the only known method of infusion for gene therapy products is intravenous.

Question 78: Was the unmanipulated (“back up”) product infused?

Indicate Yes or No if the unmanipulated product was infused. If No, continue with the Signature Lines. This question is only enabled if it is reported a Portion of product was manipulated.

Question 79: Date of unmanipulated product infusion

Report the date (YYYY-MM-DD) the unmanipulated product was infused. If the product was infused over multiple days, report the first date of infusion.

Questions 80 – 81: Specify the route of unmanipulated product infusion

Report the route by which the product was infused.

• Intravenous: refers to the infusion into the veins. Examples include infusion via central line or via catheter.
• Other route of infusion: If the product was infused other than intravenously, select this option and specify the other route. This option should be used sparingly since the only known method of infusion for gene therapy products is intravenous.

Section Updates:

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